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Self-monitoring of Spirometry & Symptoms Via patientMpower App in Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03744598
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
patientMpower Ltd.

Tracking Information
First Submitted Date November 13, 2018
First Posted Date November 16, 2018
Last Update Posted Date December 4, 2018
Actual Study Start Date November 28, 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2018)
  • Patient-measured spirometry trend over time [ Time Frame: 16 weeks ]
    Forced Vital Capacity
  • Correlation between patient-measured and clinic-measured spirometry [ Time Frame: 16 weeks ]
    Forced Vital Capacity
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03744598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 16, 2018)
  • Patient Reported Outcome Measures trend over time [ Time Frame: 16 weeks ]
    Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure
  • Correlation between patient-reported and in-clinic Patient Reported Outcome Measure [ Time Frame: 16 weeks ]
    Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure
  • Patient-reported dyspnea trend over time [ Time Frame: 16 weeks ]
    modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4)
  • Correlation between patient-reported and in-clinic dyspnea [ Time Frame: 16 weeks ]
    modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4)
  • Patient opinion on usefulness of patientMpower application [ Time Frame: 16 weeks ]
    Questionnaire (14 questions; choose 1 of 4 possible responses/question)
  • Healthcare professional opinion on usefulness of patientMpower application [ Time Frame: 16 weeks ]
    Questionnaire (7 questions; choose 1 of 4 possible responses/question)
Original Secondary Outcome Measures
 (submitted: November 13, 2018)
  • Patient Reported Outcome Measures trend over time [ Time Frame: 16 weeks ]
    Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure
  • Correlation between patient-reported and in-clinic Patient Reported Outcome Measure [ Time Frame: 16 weeks ]
    Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure
  • Patient-reported dyspnea trend over time [ Time Frame: 16 weeks ]
    modified Medical Research Council dyspnea score
  • Correlation between patient-reported and in-clinic dyspnea [ Time Frame: 16 weeks ]
    modified Medical Research Council dyspnea score
  • Patient opinion on usefulness of patientMpower application [ Time Frame: 16 weeks ]
    Questionnaire
  • Healthcare professional opinion on usefulness of patientMpower application [ Time Frame: 16 weeks ]
    Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Self-monitoring of Spirometry & Symptoms Via patientMpower App in Idiopathic Pulmonary Fibrosis
Official Title An Observational Study of Self-monitoring of Spirometry and Symptoms Via the patientMpower App in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary

Single-arm, open-label observational study in idiopathic pulmonary fibrosis (IPF) patients receiving usual care at an interstitial lung disease specialist center. The objectives are [1] to characterise the longitudinal trends of patient-measured Forced Vital Capacity (FVC) and impact of IPF on daily life Patient Reported Outcome Measures (PROM) in a cohort of patients with IPF [2] to determine the correlation (if any) between patient-measured FVC and PROMs with clinic-observed measurements and [3] to assess if longitudinal trends in patient-measured FVC are predictive of clinical health outcomes in IPF. An additional purpose is to assess the acceptability and utility of the patientMpower app in helping IPF patients and their healthcare professional caregivers manage their condition. Patients will record FVC, symptoms (e.g. dyspnea) and activity (step count) daily and PROM once a week on the patientMpower app.

The planned observation period is sixteen weeks. No additional clinic visits are required (versus usual care). In-clinic assessments of lung function, dyspnea and PROM will be done at baseline and study end. Patients and healthcare professionals will provide their opinion on utility and acceptability of patientMpower app at study end.

Detailed Description

This is a single-arm, open-label observational study in IPF patients receiving usual care at an interstitial lung disease specialist centre. The objectives are [1] to characterise the longitudinal trends of patient-measured FVC and PROM in a cohort of patients with IPF [2] to determine the correlation (if any) between patient-measured FVC and PROMs with clinic-observed measurements and [3] to assess if longitudinal trends in patient-measured FVC are predictive of clinical health outcomes in IPF. An additional purpose is to assess the acceptability and utility of the patientMpower app in helping IPF patients and their healthcare professional caregivers manage their condition. This app has been specially developed for patients with lung fibrosis and is owned by patientMpower Ltd., Dublin, Ireland. The app is downloaded to the patient's mobile phone/tablet device. Patients can record symptoms (e.g. dyspnea), activity (steps/day) and lung function (FVC) via a Bluetooth-connected hand-held spirometer. The app can also be used to remind patients to take their medicines. The app includes a PROM to capture impact of IPF on daily life (once/week).

This planned observation period is sixteen weeks. No additional clinic visits are required (compared with usual care). Only patients with a confirmed diagnosis of IPF who provide written informed consent will participate.

At a usual care visit to the IPF clinic at the study centre, the research team will discuss the study with the patient (face-to-face) and seek written informed consent. The study starts at this visit (baseline). The IPF clinic will record the usual measurements which would be done at a routine visit to assess IPF. These will include FVC, assessment of dyspnea (modified Medical Research Council score) and PROM.

After written informed consent, patientMpower Ltd. will send an information pack via e-mail and a Medical International Research Spirobank Smart spirometer to the patient. Technical support on installation of the app and spirometer will be provided by patientMpower Ltd. The patient will use the patientMpower app to record lung function, breathlessness, adherence to medication and symptoms every day at home until their next visit to the IPF clinic. Every week, patients will be reminded to record the impact of IPF on daily life PROM on the app. There will be no changes to the patient's usual care (e.g. prescribed medicines or exercises) during the study.

After about sixteen weeks, patients will return to the IPF clinic for routine assessment of their IPF. The clinic will record all of the usual measurements as at baseline. Patients and healthcare professionals will provide their opinion on the utility and acceptability of the patientMpower app. The study is concluded at this visit. However, patients can continue to use the patientMpower app and spirometer if they wish.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with idiopathic pulmonary fibrosis attending a specialist outpatient interstitial lung disease clinic.
Condition Idiopathic Pulmonary Fibrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 13, 2018)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • confirmed diagnosis of idiopathic pulmonary fibrosis
  • daily unrestricted access to smartphone/tablet device
  • has an email address
  • has home broadband or mobile data package
  • demonstrates understanding of correct use of spirometer and patientMpower app
  • able and willing to perform spirometry at home and record information on patientMpower app daily
  • gives written informed consent

Exclusion Criteria:

  • significant confusion or any concomitant medical condition which would limit teh ability of the patient to record symptoms or use a home spirometer regularly
  • new prescription of antifibrotic therapy for IPF (e.g. pirfenidone, nintedanib) within four weeks of baseline visit
  • recent exacerbation of IPF or other clinically significant change in patient's medical condition in the four weeks before the baseline visit
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Chief Scientific Officer +353872599131 colin@patientmpower.com
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03744598
Other Study ID Numbers IPF patientMpower 03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party patientMpower Ltd.
Study Sponsor patientMpower Ltd.
Collaborators Boehringer Ingelheim
Investigators Not Provided
PRS Account patientMpower Ltd.
Verification Date December 2018